Observational Study of Anti-Reflux Surgery

May 13, 2021 updated by: Torax Medical Incorporated

Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication

The Anti-Reflux Surgical Study has been established to:

  • Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
  • Track the clinical course of patients from pre-operative assessment to three years post-surgery

Study Overview

Status

Completed

Conditions

Detailed Description

This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

Study Type

Observational

Enrollment (Actual)

760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Herz Jesu Krankenhaus
      • Wien, Austria
        • Akh Wien
  • Germany
      • Berlin, Germany
        • MIC Klinik Berlin
      • Bottrop, Germany
        • Knappschafts Krankenhaus Bottrop
      • Bremen, Germany
        • Diako Bremen
      • Castrop Rauxel, Germany
        • Krankenhaus Castrop Rauxel
      • Forchheim, Germany
        • Klinikum Forchheim
      • Herne, Germany
        • Krankenhaus Herne
      • Kassel, Germany
        • Marien Krankenhaus
      • Koln, Germany
        • Uniklinikum Köln
      • Munchen, Germany
        • Arabella Klinik
      • Neuruppin, Germany
        • Ruppiner Kliniken
      • Schwabach, Germany
        • Stadtkrankenhaus Schwabach
      • Telgte, Germany
        • St. Rochus
      • Zweibrucken, Germany
        • Ev. K Zweibrucken
  • Italy
      • Milan, Italy
        • Policlínico San Donato
  • United Kingdom
      • Birmingham, United Kingdom
        • Reflux Centre
      • Epsom, United Kingdom
        • Epsom and St. Helier Hospital
      • Exeter, United Kingdom
        • Royal Devon & Exeter Hospital
      • Tunbridge Wells, United Kingdom
        • Spire Tunbridge Wells Hospital
      • Weymouth, United Kingdom
        • Weymouth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)

Description

Inclusion Criteria:

  • Individuals treated with LINX Reflux Management System or Fundoplication
  • Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
  • Individuals willing to complete questionnaires and comply with the three years of follow-up.

Exclusion Criteria:

  • Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Magnetic Sphincter Augmentation
Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System
Fundoplication
Patients treated with laparoscopic fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)
Time Frame: 3 years post-surgery
Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse
3 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torax Medical Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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